Senior Product Development Engineer -Mechanical Engineering (Hybrid Boston) (IVD and ed Dev Exp preferred)

Location: Hybrid in Boston, Massachusetts, United States

Salary: $78,400–$133,400 annually, plus potential incentives and bonus eligibility.

Company

hirify.global develops medical technologies and regulated healthcare products, including in-vitro diagnostic platforms and disposable devices.

What you will do

• Lead mechanical design of disposable device components from concept through production, including CAD models, specifications, drawings, GD&T, tolerance analysis, and verification planning.
• Design plastic and injection-molded components for high-volume disposable manufacturing, focusing on manufacturability, dimensional control, robustness, cost, and scalability.
• Collaborate with suppliers, tooling vendors, and contract manufacturers on design trade-offs, manufacturability, process validation, qualification, and production transfer.
• Own sustaining activities and resolve manufacturing and supplier component performance issues, including design change requests.
• Develop verification strategies, test protocols, engineering studies, and reports against design requirements.
• Maintain design-control documentation and provide technical guidance to junior engineers and cross-functional partners.

Requirements

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related technical discipline.
• 5+ years of product development experience in medical devices, IVD, life sciences, diagnostics, or another regulated product environment.
• Experience with mechanical and plastic component design, injection molding, high-volume disposable manufacturing, CAD, engineering drawings, verification testing, and design transfer.
• Proficiency with 3D CAD tools such as SolidWorks, plus experience with BOMs, ECOs, PLM, and document-control systems.
• Experience supporting part qualification, manufacturing transfer, and production issue resolution with suppliers, tooling vendors, and contract manufacturers.
• Strong mechanical design judgment, cross-functional communication, supplier collaboration, technical problem solving, and data-driven decision-making.

Nice to have

• Experience with microfluidic, cartridge-based, fluidic, electromechanical, or disposable diagnostic systems.
• Familiarity with design controls, risk management, verification and validation, process validation, and regulated medical-device documentation.

Culture & Benefits

• Diverse and dynamic work environment focused on challenging and rewarding work.
• 401(k) with up to a 6% employer match and no vesting period.
• Employee stock purchase plan and potential long-term incentive plan eligibility.
• Flexible time off for salaried employees, paid sick time, and paid or floating holidays.
• Parental leave, disability insurance, tuition reimbursement, and health and welfare benefits.